Quality Issue Lead - FSP

Parexel • Charleston, WV • 2d ago

Parexel FSP is looking for Issue Leads in the US or Canada !

Job Summary

The Issue Lead will be responsible for driving QE case management, ensuring that investigations are conducted thoroughly within timelines and compliance requirements, overseeing the efficiency of the process by which we conduct GCP investigations, and leveraging data to assess the efficiency / performance of the appropriate teams to perform interventions as needed.

The Issue Lead will also triage submitted cases to ascertain if the Quality Event (QE) threshold has been met and assess cases to determine if they need expedited reporting to senior management and/regulatory authorities and be accountable for managing confirmed Quality Event (QE) case through the investigation process including root cause analysis.

Job Responsibilities:

Quality Event Assessment and Investigation

This individual will be accountable for the review and classification of submitted quality issues to ascertain if the QE threshold has been met. He or she will ensure that each submitted issue is reviewed based on the established criteria, is categorized appropriately, and completed within the required time frame to ensure that events are appropriately qualified enabling expedited investigation where necessary. This individual will also be responsible for completing the necessary documentation in the eQMS system regarding the assessment of the submitted events.

Notification to Management

This individual will be responsible for initiating appropriate escalation of Critical QEs when necessary, ensuring that management is promptly and appropriately informed of quality events. The Issue Lead will be required to assess critical issues and identify these items as appropriate for escalation to leadership via the Notification to Management process.

Root Cause Analysis / Gap Analysis / Due Diligence

Once assigned a qualified event, the Issue Lead will initiate the investigation of the event to confirm the chronology and details of the issue. This individual will also be required to apply a root cause analysis, gap analysis, and / or due diligence investigation to the case. The individual will be trained in the application of an appropriate methodology and will apply it as part of the management of the case. Investigation will include reviewing relevant SOPs and supporting documents to understand what should have happened per our documented process and identifying what did not happen per the process. In addition, the investigation will include review of relevant documentation re: the event and assembling the QE team with appropriate stakeholders (SME's, study team members, etc.) to review and confirm the details of the event

Process Analysis and Improvement

This individual will be responsible for contributing to process development and improvement for case management including contributing to the development of technology (in collaboration with PFE Digital) to enable the process. In addition, the individual, along with Senior Issue Lead peers, will develop and implement guidance documents and training to assist the investigation leads in completing cases to expectations.

CAPA Plan Development and Management

This individual will hold accountability for ongoing monitoring of CAPA completion and tracking of effectiveness for implemented mitigation actions to ensure they are working as expected-for quality events, inspections and audits

Ensure implementation of QE / audit / inspection CAPAs and remediation plans

Track effectiveness checks and report on trends

Risk Mitigation Tracking

Track and ensure implementation of risk mitigations and evaluate potential impacts to business.

QUALIFICATIONS:

BS - 7+ years or equivalent MS/MBA - 6+ years or equivalent

Previous Experience:

Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory Regulatory inspection experience Process and system management experience Detailed knowledge of clinical trial processes and relationships required Knowledge of GCP requirements and applicable SOPs and regulations Project management, administrative, and technical capabilities are required, as well as effective verbal and Strong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred.

LI-REMOTE

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Parexel

Go to Apply

Share this job

Similar Jobs

Product Manager (Leadership)

Meta • Charleston, WV • 4h ago

Management & Administrative

Summary: At Meta, we're shaping innovative experiences in service of giving people the power to build community and bring the world closer together. Our multidisciplinary product teams are creating new ways to help peopl...

4h ago

Go to Apply

Product Manager (Leadership)

Meta • Charleston, WV • 4h ago

Management & Administrative

4h ago

Go to Apply

Sales Associate

United Bank • Dunbar, WV • 4h ago

Sales & Marketing

United Bank United Bank is an Equal Opportunity employer. Applicants and employees are considered for positions and are evaluated without regard to mental or physical disability, race, color, religion, gender, national o...

4h ago

Go to Apply

Host/Cashier

West Virginia Employer • Charleston, WV • 4h ago

Retail & Hospitality

Join our Kanawha City Team! We are looking for a host/hostess-cashier to greet and seat our customers. Salary range based on experience. Early close, no late nights & room for growth with our company. You'll greet gu...

4h ago

Go to Apply

Account Director Senior - NeoCloud Enterprise

Lumen • Charleston, WV • 5h ago

IT & Engineering

Lumen is the trusted network for the AI-powered world, connecting people, data, and applications through our expansive fiber network and connected ecosystem. We enable secure, high-performance connectivity across cloud,...

5h ago

Go to Apply

Electrical Design Architect

Oracle • Charleston, WV • 7h ago

IT & Engineering

Job Description Seeking a senior electrical architect to stand up, develop, govern, and continuously evolve the electrical data center design for OCI. You will be responsible for the global strategic design and product l...

7h ago

Go to Apply

Software Engineer

Cardinal Health • Charleston, WV • 9h ago

IT & Engineering

What Application Development & Maintenance contributes to Cardinal Health Information Technology oversees the effective development, delivery, and operation of computing and information services. This function antici...

9h ago

Go to Apply

Room Attendant

BBL Hospitality • Charleston, WV • 11h ago

Retail & Hospitality

Salary Range $13.50 - $15.00 Hourly Position Type Part Time Job Shift Day Category Hospitality - Hotel Description COME AND JOIN OUR AMAZING TEAM! Most positions do require weekend and holiday availability. We are please...

11h ago

Go to Apply

VP, Head of Construction Product Strategy

Zurich NA • Charleston, WV • 13h ago

Trucking & Construction

VP, Head of Construction Product Strategy 134139 Zurich North America is hiring a VP, Head of Construction Product Strategy to join our Specialties Construction team. We are open to hiring at any Zurich office location o...

13h ago

Go to Apply

Technical Business Analyst (Remote)

GovCIO • Charleston, WV • 14h ago

IT & Engineering

United States Suitability/Public Trust Fully remote Information Technology Overview GovCIO is currently hiring for a technical business analyst with testing experience to join one of our federal contract delivery teams t...

14h ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)